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Efficacy and Safety of a Thrombin-Containing Collagen-Based Hemostatic Agent in Spinal Surgery: A Randomized Clinical Trial

 Sang Man Park  ;  Dae Ryong Kang  ;  Jun Hyeok Lee  ;  Yeong Ha Jeong  ;  Dong Ah Shin  ;  Seong Yi  ;  Yoon Ha  ;  Keung Nyun Kim 
 WORLD NEUROSURGERY, Vol.154 : e215-e221, 2021-10 
Journal Title
Issue Date
Adult ; Aged ; Blood Loss, Surgical / prevention & control* ; Collagen / adverse effects ; Collagen / therapeutic use* ; Drainage ; Female ; Gelatin Sponge, Absorbable / adverse effects ; Gelatin Sponge, Absorbable / therapeutic use ; Hemostasis ; Hemostatic Techniques ; Hemostatics / adverse effects ; Hemostatics / therapeutic use* ; Humans ; Length of Stay ; Male ; Middle Aged ; Neurosurgical Procedures ; Prospective Studies ; Spine / surgery* ; Thrombin / adverse effects ; Thrombin / therapeutic use* ; Treatment Outcome
Collagen ; Hemostatic agent ; Spinal surgery ; Thrombin
Objective: When common hemostatic methods, such as suturing, cautery, and compression, fail to arrest bleeding during surgery, various local hemostatic agents are used. We aimed to evaluate the hemostatic efficacy and safety of CollaStat (Dalim Tissen Co. Ltd., Seoul, Korea), a novel thrombin-containing, collagen-based topical haemostatic agent used in spinal surgery, by comparing it with Floseal (Baxter Healthcare, Deerfield, Illinois, USA).

Methods: We performed a randomized controlled trial in 78 patients who underwent spinal surgery. The participants were randomly assigned to either an intervention group (use of CollaStat) or a control group (use of Floseal). We compared successful haemostasis rate, time to hemostasis, length of hospital stay, amount of fluid drainage, and rate of adverse events between the 2 groups.

Results: The hemostasis success rate was 94.87% in the intervention group and 97.44% in the control group. The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal since the higher limit (11.09%) of the confidence interval (CI) for the difference with Floseal was greater than the prespecified noninferiority margin of -13%. There were no statistically significant differences at the 5% level in hemostasis time, number of hemostatic agents used, hospitalization period, and amount of drainage between the 2 groups. Also, there was no incidence of medical device-related serious adverse events or adverse events in both groups.

Conclusions: The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal. Therefore CollaStat can be safely and effectively used in spinal surgery.
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1. College of Medicine (의과대학) > Dept. of Neurosurgery (신경외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Keung Nyun(김긍년)
Park, Sang Man(박상만)
Shin, Dong Ah(신동아) ORCID logo https://orcid.org/0000-0002-5225-4083
Yi, Seong(이성)
Jeong, Yeong Ha(정영하)
Ha, Yoon(하윤)
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